Back to resultsOrphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
Primary Purpose
Cirrhosis
Status
Terminated
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Orphenadrine
Baclofen
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Age 18-70 years
- Cirrhotic patients complaining of frequent muscle cramps (>3 per week) for at least a month
Exclusion Criteria:
- Patients with allergy to study drugs
- Renal impairment
- Peripheral vascular disease
- Peripheral neuropathy
- Glaucoma
- Prostatic enlargement
- Pregnancy and lactation
- Patients taking calcium channel blockers, and conjugated estrogens
- Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study
- Patients with alcoholic cirrhosis
Sites / Locations
- Tanta University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
orphenadrine group
Baclofen group
Arm Description
orphenadrine
Baclofen
Outcomes
Primary Outcome Measures
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment
Questionnaire
Secondary Outcome Measures
The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment
Visual analogue scale (VAS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04509336
Brief Title
Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
Official Title
Comparison of the Efficacy and Safety of Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID 19 Pandemic
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
orphenadrine group
Arm Type
Experimental
Arm Description
orphenadrine
Arm Title
Baclofen group
Arm Type
Active Comparator
Arm Description
Baclofen
Intervention Type
Drug
Intervention Name(s)
Orphenadrine
Intervention Description
100 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Description
initial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses
Primary Outcome Measure Information:
Title
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment
Description
Questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment
Description
Visual analogue scale (VAS)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-70 years
Cirrhotic patients complaining of frequent muscle cramps (>3 per week) for at least a month
Exclusion Criteria:
Patients with allergy to study drugs
Renal impairment
Peripheral vascular disease
Peripheral neuropathy
Glaucoma
Prostatic enlargement
Pregnancy and lactation
Patients taking calcium channel blockers, and conjugated estrogens
Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study
Patients with alcoholic cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assem Elfert
Organizational Affiliation
Faculty of Medicine, Tanta University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherif Abd-Elsalam
Organizational Affiliation
Faculty of Medicine, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
We'll reach out to this number within 24 hrs